Phase II Study of Carboplatin and Bevacizumab (Avastin) for ER Neg, PR Neg, and HER2/Neu Neg Metastatic Breast Cancer

This study has been terminated.
(This study has been terminated due to poor accrual)
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00517361
First received: August 14, 2007
Last updated: March 10, 2014
Last verified: March 2014
Results First Received: January 22, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Interventions: Drug: carboplatin
Drug: bevacizumab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Carboplatin + Avastin Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes

Participant Flow:   Overall Study
    Carboplatin + Avastin  
STARTED     11  
COMPLETED     0 [1]
NOT COMPLETED     11  
Death                 6  
The study was terminated                 5  
[1] This study has been terminated due to poor accrual.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Carboplatin + Avastin Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes

Baseline Measures
    Carboplatin + Avastin  
Number of Participants  
[units: participants]
  11  
Age  
[units: years]
Mean ± Standard Deviation
  47.7  ± 12  
Gender  
[units: participants]
 
Female     11  
Male     0  



  Outcome Measures
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1.  Primary:   Progression Free Survival   [ Time Frame: Up to 5 years ]

2.  Secondary:   Response Rate   [ Time Frame: Up to 5 years ]

3.  Secondary:   Duration of Response   [ Time Frame: Up to 5 years ]

4.  Secondary:   Correlation of Response to BRCA1 Methylation Status   [ Time Frame: Up to 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Rita Nanda
Organization: The University of Chicago
phone: 773-834-2756
e-mail: rnanda@medicine.bsd.uchicago.edu


No publications provided


Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00517361     History of Changes
Other Study ID Numbers: 15578A
Study First Received: August 14, 2007
Results First Received: January 22, 2014
Last Updated: March 10, 2014
Health Authority: United States: Institutional Review Board